Cuvitru

Last reviewed on RxList: 5/27/2021
Cuvitru Side Effects Center

What Is Cuvitru?

Cuvitru, Immune Globulin Subcutaneous (Human), 20% Solution is an immune globulin indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.

What Are Side Effects of Cuvitru?

Common side effects of Cuvitru include:

  • local injection site reactions (pain, redness, itching, swelling),
  • headache,
  • nausea,
  • fatigue,
  • diarrhea,
  • vomiting,
  • joint pain, and
  • mouth and throat pain.

Dosage for Cuvitru

The dose of Cuvitru is based on the patient's pharmacokinetic and clinical response.

What Drugs, Substances, or Supplements Interact with Cuvitru?

Cuvitru may interact with live virus vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Cuvitru During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or become pregnant while using Cuvitru; it is unknown if it would affect a fetus. It is unknown if Cuvitru passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Cuvitru, Immune Globulin Subcutaneous (Human), 20% Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Cuvitru Professional Information

SIDE EFFECTS

The most common adverse reactions observed in ≥5% of subjects were: local adverse reactions, systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

CUVITRU was administered subcutaneously in two prospective, open-label, non-controlled, multi-center studies to evaluate efficacy, safety, tolerability, and pharmacokinetics in subjects with primary immunodeficiency (PI). One study was performed in North America and the other was performed in Europe.

North American Study

In a clinical study conducted in North America, 67 out of 74 subjects treated with CUVITRU completed the study including 20/21 subjects aged 2 to <16 years old. Of the 7 subjects that discontinued treatment with CUVITRU, one subject withdrew due to fatigue (assessed as not related), 1 subject withdrew because of non-compliance, and 5 subjects withdrew for personal reasons.

A total of 4327 CUVITRU infusions were administered during the clinical study. No serious adverse reactions occurred during treatment with CUVITRU; 278 non-serious adverse reactions occurred at a rate per infusion of 0.06. Among the 4327 CUVITRU infusions, 99.3% (276/278) of adverse reactions were mild or moderate and transient in nature. Of the 278 non-serious adverse reactions (excluding infections), 83% (231/278) were rated as mild, 16% (45/278) were rated as moderate, and 1% (2/278, hemoptysis and abdominal pain) were severe.

Adverse reactions occurring in ≥5% of subjects (defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period) are shown in Table 3. No subject discontinued treatment due to local adverse reactions.

Table 3 Adverse Reactionsa in =5% of Subjects Associated with Infusions of CUVITRU

Adverse Reactions By Subject
N (%)b
(N=74 Subjects)
By Infusion
N (Rate)c
(N=4327 infusions)
Local Adverse Reactions 23 (31.1%) 96 (0.022)
Systemic Adverse Reactions 41 (55.4%) 182 (0.042)
  Headache 10 (13.5%) 50 (0.012)
  Nausea 9 (12.2%) 16 (0.004)
  Fatigue 6 (8.1%) 9 (0.002)
  Diarrhea 5 (6.8%) 5 (0.001)
  Vomiting 4 (5.4%) 5 (0.001)
a Excluding infections
b Number and percentages of affected subjects
c Rate = Total number of adverse reactions divided by the total number of infusions under treatment

Systemic adverse reactions to immune globulin intravenous in part 1 of the study occurred at a rate of 0.302 relative to a rate of 0.042 during treatment with CUVITRU. The CUVITRU systemic adverse reaction rate was approximately 7-fold lower than the immune globulin intravenous rate.

Local Adverse Reactions

The most frequent local adverse reactions are listed by frequency in Table 4. Of the total 96 local adverse reactions, 100% were either mild (92.5%) or moderate (7.5%) in severity. No severe local adverse reactions were reported. During the clinical study, no local adverse reactions were observed in 68.9% (51/74) of subjects and in 98.2% (4247/4327) of infusions. The overall rate of local adverse reactions (excluding infections) during the clinical study was 0.022 (0.021 mild and 0.002 moderate). The rate of local adverse reactions was not associated with increased rate of infusion or volume per site.

Table 4 Most Frequent Local Adverse Reactions Reported in =5% of Subjects

Events Total Number of Adverse Reactions By Subject
N (%)a
(N =74 Subjects)
By Infusion
N (Rate)b
(N=4327 infusions)
  Mild Moderate    
Pain 33 3 15 (20.3%) 36 (0.008)
Erythema 22 1 8 (10.8%) 23 (0.005)
Pruritus 7 1 4 (5.4%) 8 (0.002)
a Number and percentages of affected subjects
b Rate= Total number of adverse reactions divided by the total number of infusions under treatment

European Study

Efficacy and safety during treatment with CUVITRU were evaluated in 48 subjects in a clinical trial in Europe. CUVITRU was administered for a median treatment duration of 358 days (range: 127.0-399 days) and a mean (± SD) of 347.4 ± 47.9 days. CUVITRU treatment: 45/48 subjects treated with CUVITRU completed the study, including 23/25 subjects aged 2 to <18 years old.

A total of 2349 CUVITRU infusions were administered during this clinical study. No serious adverse reactions occurred during treatment with CUVITRU. In total, 176 local adverse reactions and 205 systemic adverse reactions were reported (adverse reaction defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period), excluding infections. Of the 205 systemic reactions, the majority (134) were mild, 70 were moderate and one event was severe (headache, assessed as temporally associated, not causally related). The rate of systemic adverse reactions (excluding infections) during treatment with CUVITRU was 0.087, and the rate of related systemic AEs (excluding infections) per infusion was 0.032. During treatment with IGIV 10% in study part 1, the rate of related systemic AEs (excluding infections) was 0.173 events per infusion. The CUVITRU related systemic adverse event rate was approximately 5-fold lower than the immune globulin intravenous rate.

Table 5 EU Study: Adverse Reactionsa in =5% of Subjects Associated with Infusions of CUVITRU

Adverse Reactions By Subject
N (%)b
(N=48 Subjects)
By Infusion
N (Rate)c
(N=2349 infusions)
Local Adverse Reactions 18 (37.5%) 176 (0.075)
Systemic Adverse Reactions 33 (68.8%) 205 (0.087)
  Headache 14 (29.2%) 59 (0.025)
  Diarrhea 9 (18.8%) 58 (0.025)
  Cough 5 (10.4%) 7 (0.003)
  Fatigue 6 (12.5) 8 (0.003)
  Arthralgia 3 (6.3%) 5 (0.002)
  Oropharyngeal pain 3 (6.3%) 3 (0.001)
a Causally Related and/or Temporally Associated (Within 72 Hour) AEs (Excluding Infections)
b Total number of affected subjects divided by the total number of subjects under treatment
c Total number of AEs divided by the total number of infusions under treatment

Local Adverse Reactions

Among the 176 local adverse reactions in total (adverse reaction defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period), none was severe. In total, 175 adverse reactions (99.4%) were mild, and 1 adverse reaction (0.6%) was moderate. The overall rate of local adverse reactions was 0.075 per infusion. The most common reactions (by subject) were infusion site pain, infusion site erythema and infusion site pruritus.

Table 6 EU Study: Most Frequent Local Adverse Reactions Reported in =5% of Subjects

Events Total Number of Adverse Reactions By Subject
N (%)a
(N =48 Subjects)
By Infusion
N (Rate)b
(N=2349 infusions)
  Mild Moderate    
Pain 34 0 10 (20.8%) 34 (0.014)
Erythema 54 0 10 (20.8%) 54 (0.023)
Pruritus 30 0 7 (14.6%) 30 (0.013)
Swelling 46 0 4 (8.3%) 46 (0.020)
a Number and percentages of affected subjects
b Rate= Total number of adverse reactions divided by the total number of infusions under treatment

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Postmarketing Experience Of Immune Globulin Products

The following adverse reactions have been identified and reported during the postmarketing use of immune globulin products administered subcutaneously:

Immune system disorders Anaphylactic reaction
Cardiac disorders Tachycardia
Nervous system disorders Tremor and paresthesia
Respiratory, Thoracic and Mediastinal disorders Dyspnea and laryngospasm
General disorders and administration site conditions Injection site reaction (such as induration and warmth) and chest discomfort

Read the entire FDA prescribing information for Cuvitru (cuvitru)

SLIDESHOW

Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow

© Cuvitru Patient Information is supplied by Cerner Multum, Inc. and Cuvitru Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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